FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
P200DTx
K Number: K142897
·
Decision Jan 16, 2015
Classifications
1
FEI Numbers
13
Registration Numbers
14
Same Product Code
21
Applicant Total
15
Review Days
105
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Basic Information
- Device Name
- P200DTx
- K Number
- K142897
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optos Plc.
- Date Received
- October 3, 2014
- Decision Date
- January 16, 2015
- Product Code
- MYC
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MYC | Ophthalmoscope, Laser, Scanning | FDA class 2 | Ophthalmic |
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Other Clearances by Optos Plc.
| K Number | Device Name | ||
|---|---|---|---|
| K233602 | P200TE (A10700) | May 9, 2024 | Substantially Equivalent |
| K231673 | P200TE (A10700) | Aug 18, 2023 | Substantially Equivalent |
| K190732 | P200TxE | Jul 31, 2019 | Substantially Equivalent |
| K173707 | P200TE | Feb 28, 2018 | Substantially Equivalent |
| K162039 | OptosAdvance 4.0 Software | Feb 8, 2017 | Substantially Equivalent |
| K134039 | DAYTONA ICG (P200TICG) | Apr 11, 2014 | Substantially Equivalent |
| K121043 | OPTOS OCT/SLO MICROPERIMETER | Feb 22, 2013 | Substantially Equivalent |
| K113696 | OPTOS ADVANCE | May 25, 2012 | Substantially Equivalent |
| K111628 | P200T | Aug 19, 2011 | Substantially Equivalent |
| K102492 | P200MAAF | Sep 30, 2010 | Substantially Equivalent |